MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIG C/R POROCOAT FEM LT SZ 4; SIGMA KNEE PRIMARY : KNEE FEMORAL

Model Number 94-0014

Device Problems Inadequacy of Device Shape and/or Size (1583); Patient-Device Incompatibility (2682); Device-Device Incompatibility (2919)

Patient Problem No Code Available (3191)

Event Date 03/04/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the porocoat femoral component did not sit flush on the distal femur when the surgeon tried to insert it.The bone was prepared according to specified sigma surgical technique.The anterior and posterior flanges made contact, but the distal femur had a gap of approximately 1-2mm.The surgeon stated that he believe the femur to be manufactured incorrectly, due to the fact that the trials fit perfectly and the implants did not.The femur was then pulled back out and a cemented femur was implanted successfully.Surgical delay of 4 minutes.Doe: (b)(6) 2020.Left knee.

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.  if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SIG C/R POROCOAT FEM LT SZ 4
• Type of Device: SIGMA KNEE PRIMARY : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9856132
• MDR Text Key: 184170033
• Report Number: 1818910-2020-08663
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295223405
• UDI-Public: 10603295223405
• Combination Product (y/n): N
• PMA/PMN Number: K062654
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 94-0014
• Device Catalogue Number: 940014
• Device Lot Number: J29T35
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/04/2020
• Initial Date FDA Received: 03/19/2020
• Supplement Dates Manufacturer Received: 03/04/2020; 04/22/2020
• Supplement Dates FDA Received: 04/01/2020; 04/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 73 YR